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Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01147770
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : July 3, 2013
Information provided by (Responsible Party):
Kyrou Dimitra, Universitair Ziekenhuis Brussel

Brief Summary:
The objective of this study is to evaluate the effect of the prolongation of luteal support on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist cycles.

Condition or disease Intervention/treatment Phase
Infertility Drug: progesterone Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Progesterone Supplementation During Early Gestations in Patients Treated With Rec FSH/GnRH Antagonist:a Randomized Controlled Trial
Study Start Date : September 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: stop progesterone Drug: progesterone
Other Name: utrogestan

Primary Outcome Measures :
  1. ongoing pregnancy rate [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age equal or less than 39
  • Body mass index between 18-29 kg/m2
  • Presence of both ovaries
  • Basal hormonal values on day 2 of the cycle
  • Embryotransfer day3 or day5
  • 1 to 3 cycles

Exclusion Criteria:

  • Endometriosis stage 3
  • Polycystic ovarian syndrome
  • Frozen or testicular sperm

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Responsible Party: Kyrou Dimitra, Resident, Universitair Ziekenhuis Brussel Identifier: NCT01147770     History of Changes
Other Study ID Numbers: CRG-45
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013

Keywords provided by Kyrou Dimitra, Universitair Ziekenhuis Brussel:
rec FSH

Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs